Reference Standard Specialist

Do you have experience with Reference Standards and are you passionate about creating a broad collaboration with Contract Manufacturing Organizations and internal stakeholders? Ready for your next career move? If so, now is your chance to join Ascendis Pharma as our new Reference Standard Specialist.

• →Plan, coordinate and document activities regarding establishment, maintenance, re-supply, recalibration and distribution/shipping of reference standards and critical analytical substances
• →Establish and maintain overview of reference standards for all purposes and product phases (development and commercial manufacturing) including storage location, stock, stability, expiry etc. for current standards as well as standards needed in the future to ensure availability of required standards
• →Establish and maintain internal guidance (SOP or guides) for reference standards
• →Make sure relevant updates of external legislation and guidelines for reference standards are implemented in the Ascendis Pharma QMS
• →Contribute as an author on regulatory documents, such as IMPD’s, IND’s, NDA’s and BLA’s and provide answers to questions from authorities – in writing or face to face during inspections. Further, contribute to assessment of inspection readiness of CMO’s.

You hold a relevant academic degree – preferably a masters in Pharmaceutical Sciences, Chemistry, Engineering, or other relevant education – and a minimum of 5 years of experience from Biotech or Pharmaceutical industry working with reference standards.

Your knowledge and experience within the reference standard area will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions. You have experience with coordination of reference standard activities, and experience with the commercial setup for resupply of reference standards. It will be an advantage if you have experience with analysis of large molecules, and preferably with polymers, proteins and/or peptides as well.

Furthermore, knowledge and practical experience in analytical sciences from the pharmaceutical industry within chromatographic analyses (HPLC) and bioassays, either from an analytical development laboratory or from a QC Laboratory will be an advantage.

You have a structured and systematic approach to solving tasks and possess outstanding skills in collaboration and communication. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive with being in contact with new people. You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You possess a high energy level and focus on details.

To succeed in this role, we also expect you to have excellent abilities in terms of keeping an overview even with many active tasks at the same time. You are a strong team player, analytical, and have a can-do attitude. Criteria of success in the role will be to ensure efficient coordination of reference standard activities for development projects as well as post-approval resupply activities. Moreover, you are expected to actively contribute to the establishment of continuous improvements to our reference standard programs and establish close and high-standard collaborations with the CMOs and internally in Ascendis Pharma.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time. To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. 

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs, your ownership of these candidates will not be acknowledged.